Auto-Injector Apparatus

ABSTRACT

An auto-injector apparatus includes a flexible container containing a liquid medicant, a needle communicated with a container, a housing with a container being received in the housing, a pump disposed in the housing and positioned to engage the flexible container and expel the medicant from the container through the needle upon relative movement between the pump and the container, and a main drive spring operably associated with the needle to extend the needle from a first needle position wherein the needle is completely received in the housing to a second needle position wherein the needle protrudes from the housing. The pump may be a roller.

This application claims priority from United Kingdom Patent ApplicationNo. 0821492.6 for “Integrated Auto-Injector Cartridge” filed on Nov. 25,2008.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to auto-injector apparatus forinjecting medicants into a patient.

2. Description of the Prior Art

To aid convenience in injecting drugs it is desirable to simplify theprocess by inserting the needle into the delivery site, delivering thedrug and subsequently sheathing the needle with minimal user input. Theprior art has included a number of auto-injector devices for performingthis process. Most prior art auto-injectors use glass based syringes orcartridges as the primary packaging for the drug or medicant.

There is a continuing need for improved auto-injector apparatus that aresimple and reliable in their use and economical in their manufacture.

SUMMARY OF THE INVENTION

In one aspect an auto-injector apparatus includes a flexible containercontaining a liquid medicant, a needle communicated with the flexiblecontainer, a housing with the container being received in the housing, apump disposed in the housing and positioned to engage the flexiblecontainer and expel the medicant from the container through the needleupon relative movement between the pump and the container, and a maindrive spring operably associated with the needle to extend the needlefrom a first needle position wherein the needle is completely receivedin the housing to the second needle position wherein the needleprotrudes from the housing. The pump may include a roller.

In a second aspect a method of auto-injecting a liquid medicant into apatient includes placing a proximal end of an auto-injector apparatusagainst the patient's body, releasing a main spring, driving a needleproximally within the apparatus with the main drive spring so that theneedle extends out of the proximal end of the apparatus therebyinserting the needle in the patient's body, and creating relative motionbetween a pump and a flexible medicant container within the apparatusand thereby forcing the medicant out of the flexible container throughthe needle into the patient's body. The pump may include a roller.

In another aspect an auto-injector apparatus includes a flexiblecontainer containing a liquid medicant, a needle communicated with thecontainer, and a roller positioned to engage the flexible container andexpel the medicant from the container upon relative movement in adisplacement direction between the roller and the container, wherein theflexible container has a width transverse to the displacement directionand the width varies along the displacement direction.

Numerous objects, features, and advantages of the present invention willbe readily apparent to those skilled in the art upon a reading of thefollowing disclosure when taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D comprise a schematic series of figures illustrating themanufacture and the use of an embodiment of the auto-injector apparatus.

FIG. 1A illustrates the manufacture of the embodiment of FIGS. 1A-1D.

FIG. 1B illustrates the embodiment of FIGS. 1A-1D ready for use.

FIG. 1C illustrates an intermediate step in the use of the embodiment ofFIGS. 1A-1D wherein the needle has been uncovered as it would duringinsertion into a patient's body.

FIG. 1D illustrates a further stage in the use of the embodiment ofFIGS. 1A-1D wherein a coil strip spring has rolled over the flexiblecartridge to inject the medicant.

FIGS. 2A-2G comprise a sequential series of illustrations of the stepsof usage of an auto-injector apparatus having an injector device usingreplaceable cartridges.

FIG. 2A shows the device after usage and ready for reloading.

FIG. 2B shows the device opened for removal of the spent cartridge.

FIG. 2C shows a replacement cartridge in place within the device.

FIG. 2D shows the device closed and ready for use.

FIG. 2E shows the device as it would appear with its proximal endengaged against the patient's body and with a trigger on its distal enddepressed.

FIG. 2F illustrates the device with the needle extended from the deviceas it would appear during insertion into the patient's body andinjection of the medicant.

FIG. 2G shows the device with the needle withdrawn and back in the samecondition as FIG. 2A.

FIG. 3 is an end view of an embodiment of a replaceable cartridge for anauto-injector apparatus.

FIG. 4 is a right side elevation view of the apparatus of FIG. 3.

FIG. 5 is a bottom view of the apparatus of FIG. 3.

FIG. 6 is a top plan view of the apparatus of FIG. 3.

FIG. 7 is a perspective exploded view of the apparatus of FIG. 3.

FIGS. 8A-8B comprise a sequential series of perspective views showingthe operation of the apparatus of FIG. 3.

FIG. 8A shows a perspective view of the apparatus of FIG. 3 ready foruse.

FIG. 8B shows a perspective view of the apparatus of FIG. 3 wherein aneedle protection frame is shown in a collapsed position with the needleextended therefrom for insertion into the patient and injection of amedicant.

FIGS. 9A-9C comprise a perspective end view of the needle protectionframe and needle hub of the apparatus of FIG. 3 illustrating the mannerin which a releasable interlock on the needle hub is released uponclosure of the lid of the device.

FIG. 9A shows the interlock in a locked position prior to closure of thelid of the device.

FIG. 9B illustrates with downward vertical arrows the application ofdownward force as would occur by two pins (not shown) of the lid uponclosure.

FIG. 9C shows the collapsed position of the needle protection frame withthe frame arms sliding through the needle hub.

FIG. 10 is an exploded perspective view of an embodiment of anauto-injector apparatus for use with replaceable cartridges.

FIGS. 11, 13, 16, 17, 19, 21 and 23 comprise a sequential series ofperspective views of the apparatus of FIG. 10 showing a series of stepsin the use of the apparatus.

FIG. 11 is a perspective view of the apparatus of FIG. 10 in a firstposition prior to opening of the device and prior to loading a cartridgein the device.

FIG. 12 is a plan view of the apparatus of FIG. 11.

FIG. 12A-A is an elevation section view of the apparatus of FIG. 12taken along line A-A.

FIG. 12B-B is an elevation section view of the apparatus of FIG. 12taken along line B-B.

FIG. 13 is a perspective view of the apparatus of FIG. 10 in a secondposition wherein the lid has been opened and prior to placement of acartridge in the device.

FIG. 14 is a plan view of the apparatus of FIG. 13.

FIG. 14A-A is an elevation section view of the apparatus of FIG. 14taken along line A-A.

FIG. 14B-B is an elevation section view of the apparatus of FIG. 14taken along line B-B.

FIG. 16 is a perspective view of the apparatus of FIG. 10 in a thirdposition with a cartridge having been placed within the device.

FIG. 16 is a plan view of the apparatus of FIG. 16.

FIG. 16A-A is an elevation section view of the apparatus of FIG. 16taken along line A-A.

FIG. 16B-B is an elevation section view of the apparatus of FIG. 16taken along line B-B.

FIG. 17 is a perspective view of the apparatus of FIG. 10 in a fourthposition with the cartridge in place and with the lid closed.

FIG. 18 is a plan view of the apparatus of FIG. 17.

FIG. 18A-A is an elevation section view of the apparatus of FIG. 18taken along line A-A.

FIG. 18B-B is an elevation section view of the apparatus of FIG. 18taken along line B-B.

FIG. 19 is a perspective view of the apparatus of FIG. 10 in a fifthposition wherein the needle is protruding from the device as it wouldupon insertion into a patient's body, but prior to injection of themedicant into the patient.

FIG. 20 is a plan view of the apparatus of FIG. 19.

FIG. 20A-A is an elevation section view of the apparatus of FIG. 20taken along line A-A.

FIG. 20B-B is an elevation section view of the apparatus of FIG. 20taken along line B-B.

FIG. 21 is a perspective view of the apparatus of FIG. 10 in a sixthposition after the medicant has been injected into the patient. It isnoted that FIG. 21 appears the same as FIG. 19, but the positions of theinternal components have changed.

FIG. 22 is a plan view of the device of FIG. 21.

FIG. 22A-A is an elevation section view of the apparatus of FIG. 22taken along line A-A.

FIG. 22B-B is an elevation section view of the apparatus of FIG. 22taken along line B-B.

FIG. 23 is a perspective view of the embodiment of FIG. 10 in a seventhposition wherein the needle has been withdrawn back into the device.

FIG. 24 is a plan view of the device of FIG. 23.

FIG. 24A-A is an elevation section view of the apparatus of FIG. 24taken along line A-A.

FIG. 24B-B is an elevation section view of the apparatus of FIG. 24taken along line B-B.

FIG. 25 is an exploded perspective view of an embodiment of anauto-injector apparatus designed for a single use.

FIGS. 26A-26H illustrate several variations on the size and shape of theflexible drug container. FIG. 26A shows a container of relatively lowvolume. FIG. 26B shows a container of relatively high volume. FIG. 26Cshows dual parallel containers which allow two drugs to be mixed duringinjection. FIG. 26D shows dual containers in series which allow two drugcomponents to be mixed during injection. FIGS. 26E-H show severalvariations of a profiled container which affects the rate of delivery ofmedicant.

FIG. 27 is a schematic perspective view of an embodiment of an injectionapparatus having a longitudinally fixed roller.

FIG. 28 is a schematic perspective view of another embodiment of aninjection apparatus having a longitudinally fixed roller.

FIG. 29 is a schematic perspective view of another embodiment of aninjection apparatus having a longitudinally fixed roller.

FIG. 30 is a schematic perspective view of another embodiment of aninjection apparatus having a longitudinally fixed roller.

FIGS. 31A and 31B schematically show two positions of an alternativepump apparatus including an inflatable balloon pump.

FIGS. 32A and 32B schematically show two positions of an alternativepump apparatus including a pair of magnets on opposite sides of theflexible container.

FIGS. 33A and 33B schematically show two positions of an alternativepump apparatus including an electromagnet and a magnetically attractedmass.

FIGS. 34A and 34B schematically show two positions of an alternativepump apparatus including a source of fluid pressure communicated withthe interior of the flexible container.

FIG. 35 is a plan view of a cartridge contained in secondary packaging.

FIG. 36 is a side view of the packaging of FIG. 35.

FIG. 37 is a section view taken along line 37-37 of FIG. 36.

FIG. 38 is a plan view of a cartridge in another embodiment of secondarypackaging.

FIG. 39 shows the packaging of FIG. 38 with a cover peeled back.

FIG. 40 is a side view of the packaging of FIG. 39.

FIG. 41 is a plan view of a single use injector device contained insecondary packaging.

FIG. 42 is a plan view of a single use device having a transparentwindow covered by a pull strip.

FIG. 43 shows the device of FIG. 42 after the pull strip has been pulledto expose the cartridge through the transparent window.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The Embodiment ofFIGS. 1A-1D

FIGS. 1A-1D schematically illustrate one embodiment of an auto-injectorapparatus.

FIG. 1A schematically illustrates a step in the assembly of anauto-injector apparatus 10, a more complete assembly of which is shownin FIG. 1B. In FIG. 1A, a needle sub-assembly 12 is laid in place upon aflat portion of a flexible substrate 14.

The flexible substrate 14 begins as a flat flexible sheet of materialwhich may for example be a polymer material and may include a laminatedmetal layer as further described below. A drug containment volume 16,which may also be referred to as a flexible container 16, has beenformed in a blister manner into the flat flexible sheet. Also formedinto the sheet are a necked down passage 18, a manifold portion 20, anda bleed vent 22.

In FIG. 1B, the substrate 14 has been folded over about a fold line 24and the flat portions of the flexible substrate have been sealedtogether where they engage. Also, the necked down passage 18, which mayalso be referred to as neck 18, has been sealed to isolate needle 26 andclose the drug containment volume 16 at its proximal end.

It is noted that in this description, the term “proximal” is used torefer to the end of the apparatus that is closest to or engaged with thepatient when the apparatus is in use to inject the medicant into thepatient's body. Thus the sharp end 28 of the needle 26 is referred to asthe proximal end of needle 26. Similarly, the proximal end of theapparatus 10 is indicated at 30. Accordingly the distal end of theapparatus 10 is indicated at 32.

After the substrate 14 has been folded over and the flat portions andthe neck 18 have been sealed, the drug containment volume 16 is filledwith a drug or medicant which is placed through the top end 34 of thestill open drug containment volume 16, then the top end is closed orsealed as indicated at 36 in FIG. 1B.

Then, the volume of the drug containment volume 16 is compressedslightly to expel residual air through the bleed feature 22 after whicha neck 38 of the bleed feature 22 is sealed to completely seal the drugcontainment volume 16.

Then the back side of the substrate 14 adjacent the drug containmentvolume 16 is bonded to an unrolled coil spring strip 40 also sometimesreferred to as a Tensator spring 40.

FIGS. 1C and 1D schematically illustrate two steps in the use of theapparatus 10. In FIG. 1C, the actuation of the apparatus 10 has begun,and the drug containment volume 16 and needle sub-assembly 12 includingneedle 26 have moved axially forward in a proximal direction forcing theneedle 26 to protrude through the front 42 of the substrate material 14with excess material bunching as indicated at 44 near the root of theneedle 26. It will be understood that this step in the actuation, andthe proximal movement of the drug containment volume and needlesub-assembly 12 is accomplished by means of an actuating mechanism whichis not shown in FIGS. 1A-1D.

In FIG. 1D, the coil spring strip 40 has been released and has rolledforward proximally into its natural coiled state. As the loop of thecoil spring strip 40 rolls forward, it compresses the flexible drugcontainment volume 16 and expresses the drug contained therein throughthe passage 18 and through the needle 26 into the patient. The loop maybe described as an integral roller portion 41 of the coil spring strip40.

Several features are provided by the integrated assembly of theapparatus 10 shown in FIGS. 1A-1D.

The apparatus 10 provides drug containment in the flexible containerdefined by the drug containment volume 16 and the surrounding flexiblesubstrate 14.

The properties of the material selected for the substrate 14 which formsthe flexible barrier around the drug containment volume 16 may beselected as appropriate.

The folded substrate material about the needle sub-assembly 12 as seenin FIG. 1D provides needle sterility until the point of use of theapparatus 10.

The frangible seal provided at neck 18 provides a dry needle in storage.

The bleed feature 22 provides a means of air removal during filling.

The potential is provided for having two of the drug compartments 16formed in the substrate 14 which provides a lyophilized powder option,as is for example further discussed below with regard to FIG. 26D.

The apparatus 10 allows for flexible fill volumes by selection of thesize of the drug containment volume 16 formed in the substrate 14.

The use of a roller to express the drug from the flexible volume 16allows full delivery of contents from the volume 16 through the needle26.

The apparatus 10 is compact in size and relatively low in cost,

The apparatus 10 aids convenience in injecting drugs by simplifying thedrug injection process by inserting the needle into the delivery site,delivering the drug and subsequently sheathing the needle with minimaluser input.

As best seen in FIG. 1A, the needle sub-assembly 12 includes a needlehub 46 which as shown in FIG. 1B is structurally connected to theflexible container 16 via the folded layers of the substrate 14, and isfluidly connected to the interior of container 16 via the passage 18 andthe manifold portion 20 which communicate with an opening (not shown) inthe needle hub 46 which in turn communicates with the needle 26.

The needle 26 is attached to the needle hub 46 and extends proximallyfrom the needle hub 46. A needle protection frame 48 is connected to theneedle hub 46. The frame 48 includes first and second transverselyspaced frame arms 60 and 52 which are supported from the needle hub 46on opposite sides of the needle 26 and extend proximally beyond theproximal end 28 of needle 26. Laterally inward extending supports 54 and56 are defined on the proximal ends of arms 50 and 52, respectively, toaid in supporting the folded over substrate 14 as seen in FIG. 1B. Thearms 50 and 52 hold the front 42 of substrate material 14 away fromproximal end 28 of needle 26.

When the container 16, needle hub 46 and needle 26 move proximallyforward from the position of FIG. 1B to the position of FIG. 1C relativeto the front 42 of laminated substrate 14, the frame arms 50 and 62 foldup in an accordion like manner as shown in FIG. 1C to allow the relativemovement between needle 26 and the front 42 of the laminate 14. Theneedle hub 46 and the needle 26 may be described as being displaceablerelative to the frame 48 in a proximal direction to insert the needle 26into a patient.

Those portions of the laminated material 14 folded over the needle 26between the arms 60 and 62 as seen in FIG. 1B may be referred to as aflexible needle pouch 58 connected to the frame 48 and covering theneedle 26 to maintain the needle 26 in a sterile condition prior to use.As illustrated, the pouch 58 is collapsible so that the needle 26 canprotrude through the pouch 58 upon proximal displacement of the needlehub 46 and needle 26 relative to the frame 48.

The two sheets of the substrate 14 forming the needle pouch 58 can bedescribed as a sheet of flexible material 14 folded at fold 24 into twosheet portions joined together along at least two sides as indicated at60 and 62, the two sides 60 and 62 extending generally parallel to theneedle 26 which may be described as being transverse to the fold 24.

The flexible container 16 may be described as being made up of first andsecond layers of the flexible substrate material 14 joined together todefine a container space 16 therebetween, the first and second layers ofthe substrate 14 further defining the passages 18 and 20 communicatingthe container space 16 with the needle hub 46.

As previously noted, the necked down portion 18 of the passage istemporarily closed to provide a frangible seal temporarily closing thepassage 18 to isolate the needle 26 from medicant in the volume 16. Thatfrangible seal is formed by joining portions of the first and secondlayers of the substrate 14 so that they are lightly sealed togetheracross the passage 18 thus blocking the passage 18 until the pressurewithin the container 16 is sufficient to break that seal across the neckdown portion 18 by causing the two layers to peel away from each other.

The flexible container 16 may also be described as comprising first andsecond layers of the flexible substrate 14, which may be described as aflexible film 14, joined together around at least part of a containmentperimeter so that the interior volume of container 16 is a containmentspace defined between unjoined portions of the first and second layersof the substrate 14. As is apparent in FIGS. 1B and 1C, the container orcontainment space 16 is an elongated space having a length 64 extendinggenerally parallel to a proximal/distal axis 66 of the container 16, andhaving a width 68 transverse to and less than the length 64, so that thecontainment space 16 has two lengthwise sides 63 and 66 parallel tolength 64, a distal side 70 and a proximal side 72. The first and secondlayers of the substrate material 14 are joined together on at least thetwo lengthwise sides 63 and 65 and the distal side 70, and the twolayers of substrate 14 are further joined together to define thepassages 18 and 20 communicating the proximal side 72 of the containmentspace 16 with the needle hub 46.

The coil spring strip 40 may be described as a drive spring 40 havingits integral roller portion 41 which rolls over the flexible container16 after the needle 26 is extended to the position shown in FIGS. 1C and1D.

The Embodiment of the Multi-Use Apparatus of FIGS. 2-24

FIGS. 2A-2G comprise a sequential series of illustrations showing themanner of usage of a multi-use auto-injector apparatus which isgenerally designated by the numeral 100. The apparatus 100 includes ahousing 102 having a lid 104 which may be opened as indicated in FIGS.2B and 2C to allow removal and replacement of a cartridge assembly 106.

The Cartridge Assembly

The details of construction of the cartridge assembly 106 are seen inFIGS. 3-9. FIG. 3 is a proximal end view of the cartridge assembly 106.FIG. 4 is a right side elevation view of the cartridge assembly 106.FIG. 5 is a bottom view of the cartridge assembly 106. FIG. 6 is a topplan view of the cartridge assembly 106. FIG. 7 is a perspectiveexploded view showing the components of the cartridge assembly 106.FIGS. 8A and 8B show the cartridge assembly in two different operatingpositions.

The cartridge assembly 106 includes a flexible container 108 that asschematically illustrated in FIG. 7 includes a liquid medicant 110. Asbest seen in FIG. 7, the flexible container 108 comprises first andsecond layers 112 and 114 of flexible film joined together. As shown inFIG. 6, the layers 112 and 114 of film are joined together around atleast a part of a containment perimeter defined by two lengthwise sides116 and 118, a distal side 120 and a proximal side 122. The interior offlexible container 108 may be described as a containment space which isdefined between unjoined portions of the first and second layers 112 and114. That containment space is an elongated space having a length 124extending generally parallel to a proximal/distal axis 128 of thecontainer 108, and having a width 130 transverse to and less than thelength 124, so that the containment space within container 108 has thetwo lengthwise sides 116 and 118 mentioned plus the distal side 120 andthe proximal side 122.

The first and second layers 112 and 114 are joined together along thetwo lengthwise sides 116 and 118 in the areas as indicated at 132 and134, and along the distal side 122 in the area as indicated at 136.

The upper layer of film 112 has a manifold portion 138 formed therein asbest seen in FIG. 7. The manifold portion 138 is shaped so as to closelyfit over a distal portion of a central hub portion 146 of a needle hub140. The needle hub 140 includes the central hub portion 146 and upperand lower hub clamps 148 and 150. The upper and lower hub clamp portions148 and 150 have slots such as 176 therein for receiving positioningribs such as 178 of central hub 146 therein. The upper and lower clampportions 148 and 160 are held together by flexible arms such as 180having laterally inward extending protrusions such as 182 which snap fitbelow ledges such as 184 on the lower clamp part 150.

As generally indicated by the dotted line 142 in FIG. 6, a passage 142communicates the interior of the container 108 with the manifold portion138 and thus with the needle hub 140. After the container space withinthe flexible container 108 has been filled with the medicant 110, thepassage 142 is temporarily sealed by a frangible seal 143 which isformed by pressing the first and second layers 112 and 114 of flexiblefilm together and lightly sealing the two together across the passage142 so as to temporarily seal the medicant within the flexible container108. As is further described below, during use of the apparatus 106 aroller will roll across the flexible container 108 from its distal end120 toward its proximal end 122 and the pressure within the flexiblecontainer 108 will break the seal 143 by causing the layers 112 and 114to peel apart within the area of the passage 142 thus allowing theliquid medicant to flow from the container 108 through the passage 142and through the central hub portion 146 of needle hub 140 to a needle144.

The hub 140 and needle 144 are part of a needle subassembly 152 whichfurther includes a needle protection frame 154 connected to the needlehub 140 and including a frame proximal end 156 extending proximallybeyond a proximal end 158 of needle 144. As is apparent in viewing FIGS.8A and 8B, the needle hub 140 and needle 144 are displaceable relativeto the frame 164 in a proximal direction to insert the needle 144 into apatient.

The needle protection frame 154 includes first and second transverselyspaced frame arms 168 and 160 supported from the needle hub 140 onopposite sides of the needle 144 and extending proximally beyond theproximal end 168 of needle 144.

The frame 164 further includes a front bar 162 made up of upper andlower front clamp halves 164 and 166, spanning between the proximal endsof the frame arms 158 and 160 to protect the proximal end 158 of theneedle 144 when the needle 144 is in an initial position correspondingto FIGS. 4-6 and FIG. 8A. The upper and lower front clamp portions 164and 166 are held together by flexible arms such as 185 on the upperclamp portion having laterally inward extending protrusion 188. As bestseen in FIG. 3, the front bar clamp portions have recesses definedtherein which form an opening 168 through the front bar 162 throughwhich the needle 144 passes when the needle moves proximally relative tothe frame 154 to insert the needle into a patient. Such proximalmovement is illustrated in the position of FIG. 8B wherein the needle144 has passed through the opening 168.

The upper hub clamp 148 of needle hub 140 includes first and secondcylindrical openings 169 and 171 defined therethrough within which areslidably received the cylindrical arms 158 and 160, respectively.

As best seen in comparing FIGS. 8A and 8B, the frame arms 168 and 160slide through the openings 169 and 171 of needle hub 140 when the needlehub 140 and needle 144 are displaced proximally relative to the frame154 to insert the needle 144 into a patient.

The needle sub-assembly 152 preferably includes a flexible needle pouch170 connected to or supported from the frame 164 and covering the needle144 to maintain the needle 144 in a sterile condition prior to use. Theneedle pouch 170 is collapsible so that the needle 144 can protrudethrough the pouch 170 upon proximal displacement of the needle hub 140and needle 144 relative to the frame 154 as illustrated in FIG. 8B. Theflexible needle pouch 170 is preferably formed from two sheets offlexible film in a manner similar to that described for formation of theflexible container 108 from the two sheets 112 and 114. The needle pouch170 has an opening 172 at a distal end portion that is similar in sizeand shape to the opening or manifold portion 138 described above, whichopening 172 closely fits over a proximal portion 174 of the central hub146. Needle pouch 170 may be formed from a sheet of flexible materialfolded at a fold line 186 into two sheet portions joined together alongat least two sides transverse to the fold.

The sheets 112 and 114 are preferably joined together by welding of thesheet material. The welding may be accomplished by application of heat,by application of radio frequency energy, by application of ultrasonicenergy, by friction welding, or any other suitable welding technique.Alternatively the sheets can be joined by solvent bonding or the use ofany other suitable adhesive. The central hub 146 is preferably formed ofplastic and is preferably joined to the flexible container 108 and tothe needle pouch 170 by welding of the flexible material to the centralhub 146.

In any of the embodiments disclosed herein wherein two separate sheetsare joined together, such as sheets 112 and 114, an equivalent structuremay be provided by folding a single sheet. Similarly, in any of theembodiments disclosed herein wherein a single sheet is folded to formtwo overlying layers, an equivalent structure may be provided by twoseparate sheets joined together.

Also, instead of using a needle pouch 170 constructed from two sheets ora folded sheet of flexible material, a formed cylindrical rubber orplastic sheath or nipple may be used and directly attached to needle hub140.

FIGS. 9A-9C illustrate the operation of a releasable lock 188 operablyassociated with the frame arms 158 and 160 and the needle hub 140. Thereleasable lock 188 can lock the needle protection frame 164 in thelocked position as shown in FIG. 9A wherein the frame arms 158 and 160are prevented from sliding distally relative to the needle hub 140, andan unlocked position as illustrated in FIGS. 9B and 9C, wherein theneedle protection frame 154 is allowed to slide distally relative to theneedle hub 140. The releasable lock 188 includes resilient locking arms190 and 192 which in their unbiased position as shown in FIG. 9A arereceived in notches such as indicated at 194 in the distal ends of thearms 168 and 160. When the flexible arms 190 and 192 are received in thenotches 194 they prevent the arms 168 and 160 from sliding distallythrough the needle hub 140.

Referring back to the series of FIGS. 2A-2G, when the lid 104 isreturned to a closed position as shown in FIG. 2D a pair of pins (notshown) on the underside of the lid 194 engage the flexible arms 190 and192 and push them downward as indicated by arrows 196 and 198 in FIG. 9Bso as to permit the arms 158 and 160 to slide distally as shown in FIG.9C.

The flexible materials making up the first and second layers 112 and 114of film which are used to make the flexible container 108 may beselected based upon numerous desirable properties for the flexiblecontainer 108. For example, the flexible container 108 may beconstructed from a transparent or translucent material so that an extentto which the container 108 is filled with medicant can be observed bythe user. Also, the materials from which the container 108 ismanufactured may be selected based upon their properties as oxygen andmoisture barriers for protection and shelf life of the medicantcontained in the container 108. One preferred such material which willbe opaque and will provide very high barrier properties is a flexiblemetallic material which includes an aluminum lamination. Other metallicfilms, layers or foils could also be used. For example a metallic layercould be vacuum deposited upon an underlying flexible substrate.

Numerous examples of possible flexible materials from which the firstand second layers 112 and 114 of film may be selected are set forth inthe following Table I along with some approximate properties of thesematerials as oxygen and moisture barriers. In each case the product isdescribed as a lamination of three materials.

TABLE I Oxygen Barrier Moisture Barrier Total (1 ml. volume) (1 ml.volume) Thickness (g/m²/ (cc/m²/ Product μm day) ppm day) ppm PP/20μEVOH/PP 160 1.86 1897 0.2 204 PP/40μ EVOH/PP 160 1.93 1969 0.1 102PP/PET•SIOx/PP 112 0.5 510 0.5 510 PP/23μ PCTFE/PP 100 0.23 235 120122400 PP/51μ PCTFE/PP 100 0.11 112 55 56100 PP/PET•SIOx/PP (Super) 1120.001 1 0.001 1 Lacquer/Aluminum/PP 110 0 0 0 0

The abbreviations for the products in the first column of Table I referto the following materials:

-   -   1. PP is polypropylene.    -   2. PCTFE is polychlorotrifluoroethylene.        Polychlorotrifluoroethylene is a fluoropolymer that has the best        water barrier properties of all suggested polymers. It is also        known under the trademark ALCAR®, which is a product of        Honeywell.    -   3. EVOH is ethylene vinyl alcohol. Ethylene vinyl alcohol is a        polymer that has outstanding oxygen barrier properties, but is        prone to moisture transmission and therefore must be all        protected by outer layers.    -   4. SIOx is silicium oxide. It is a very thin glass layer coated        onto a PET film. The coating process can be achieved in many        different ways.

The use of a transparent or translucent drug containment film may besuitable for drugs that have low dissolved oxygen and low loss ofmoisture stability requirements. It has the advantage that visualinspection of the drug at time of manufacture and by the patient beforeinjection is possible. The disadvantage is potential susceptibility toultraviolet radiation. Many of the polymers listed in Table I may beobtained in a sufficiently transparent form that the level of the liquidmedicant in the container can be visualized, although they may not befully transparent.

For drugs that have higher dissolved oxygen and low loss of moisturestability requirements, an opaque containment film including a foillayer within the film, such as aluminum foil, may be desirable. Such aconfiguration has the advantage of less susceptibility to ultravioletradiation. It has the disadvantage that visual inspection of the drug attime of manufacture and by the patient before injection may not bepossible.

External Packaging:

Another option is to utilize a transparent flexible drug containmentfilm which is sealed inside metal foil secondary packaging. This optionis suitable for drugs that have high dissolved oxygen and low loss ofmoisture stability requirements. It has the advantage that visualinspection of the drug at the time of manufacture and by the patientbefore the injection is possible, and that it is less susceptible toultraviolet. This solution may also be suitable for drugs that have veryhigh stability requirements, i.e. if the secondary packaging is sealedunder nitrogen or contains an oxygen absorbing material. Such anembodiment is shown for example in FIGS. 35-37 wherein the cartridge 106is shown in place within a foil package 700. The package 700 is madefrom a bottom layer 702 and a top layer 704 sealed together around theirperiphery. Top layer 704 is raised as best seen in FIGS. 36 and 37 tocreate an interior space 710 for storage of the cartridge 106. Notches706 and 708 are preformed in the package 700 so that it may be tornapart across the width of the package so that the cartridge 106 may beremoved for use. The package 700 is preferably made of a metal foilmaterial which will be impermeable to moisture and air. As noted theinterior 710 of the package may be sealed under nitrogen or contain anoxygen absorbing material. The flexible container 108 will be made oftransparent material so that when it is manufactured, and when it isremoved from package 700 for use, it may be visually inspected to insurethat it is filled with medicant and that the medicant is clear andcontains no particulates.

Another form of external packaging is shown in FIGS. 38-40. In this casethe cartridge 106 is contained in an opaque package 720, which again ispreferably constructed from a metal foil material such as aluminum.Package 720 is made from a bottom layer 722 and a top layer 724 joinedaround their periphery to define an interior 726. A window 728 isdefined in top layer 724 and is initially covered by a peelable strip730 as shown in FIG. 38. As shown in FIGS. 39 and 40 the strip 730 ispeeled back so that the cartridge 106 is visible and can be removed fromthe packaging. Alternatively the entire top layer can be designed to bepeeled back from the bottom layer.

Both of the packaging embodiments 700 and 720 just described areintended for packaging of cartridges for use in multi-use injectordevices as further described below. Other external packagingarrangements for single use injector devices are described below withregard to FIGS. 41-43.

Container Shapes:

The shape and dimensions of the flexible container 108 may be selectedbased upon various considerations. Several alternatives are shown inFIGS. 26A-26H, and it will be understood that due to the designflexibility provided by the use of molding the flexible film toconstruct the flexible container 108, any desired shape can be readilyformed and utilized with the apparatus 100.

For example, FIGS. 26A and 26B show how the volume of liquid medicantcontained in the flexible container 108 may be readily changed simply byforming the container 108 to have a smaller volume. The container 108 inthe embodiment of FIG. 26B has a volume approximately ten times that ofthe container 108 in the embodiment of FIG. 26A.

The embodiment of FIG. 26C includes two flexible containers 108′ and108″ in a parallel relationship, both of which are communicated with theneedle hub 140 through frangible seals such as the frangible seal 143described above, thus permitting the mixing of two liquid drugs duringthe injection process.

The embodiment of FIG. 26D includes two flexible containers 108′ and108″ in series. The first container 108′ is separated from the secondcontainer 108″ by a first frangible seal 143′. The second container 108″is separated from the needle hub 140 by a second frangible seal 143″.The first container 108′ is filled with a liquid drug component and thesecond container 108″ is filled with a dry drug component. As the roller210 rolls forward it first pressurizes first container 108′ to burstfirst frangible seal 143′ so that the liquid component flows into thesecond container 108″ and begins to mix with the dry drug component. Asthe roller 210 continues to roll forward the second frangible seal 143″bursts and the mixed liquid and dry drug components are expelled throughthe needle.

The embodiments of FIGS. 26E-26H show profiled containers 108 whichaffect the flow rate of delivery of drug from the container 108 as themechanism rolls a roller across the container to squeeze the medicantout of the container.

In the embodiments of FIGS. 26E-26H the roller 210 is positioned toengage the flexible container 108 and expel the medicant from thecontainer upon relative movement between the roller 210 and container108 in a displacement direction 211 shown in FIG. 26E. Displacementdirection 211 is a longitudinal direction parallel to the axis 128 ofcartridge 106. The roller 210 has a rotational axis 213 transverse tothat displacement direction 211.

In the embodiment shown in FIG. 26E the flexible container 108 has awidth 130 transverse to the displacement direction 211, the width 130varying along the displacement direction. The roller 210 first engagesthe container at a first position shown in solid lines and roller 210moves in the displacement direction toward a second position shown indotted lines. In the embodiments of FIGS. 26E and 26G, the width 130 ofthe container 108 at the second engagement position of roller 210 shownin dashed lines is less than the width of the container at the firstengagement position, so that the speed of injection of medicantdecreases during relative movement of the roller 210 between the firstand second engagement positions. This assumes that the roller 210 movesat a constant speed in direction 211. In the embodiments of FIGS. 26Eand 26G the width 130 of the container continuously decreases from thefirst engagement position to the second position.

Conversely, in the embodiment of FIG. 26F, the width of the container108 at the second engagement position of the roller 210 shown in dashedlines is greater than the width of the container at the first engagementposition of the roller shown in solid lines, so that a speed ofinjection of medicant increases during the relative movement of theroller 210 between the first and second engagement positions.

Finally, as shown in FIG. 26H, the width 130 of the container 108 canvary in multiple aspects. In the embodiment of FIG. 26H, the width 130first decreases, then increases, which provides an alternating injectionspeed which first decreases and then increases.

It will be appreciated that the profile of the flexible container can bedesigned so as to provide any desired changing injection speed profile.

The Multi-Use Dispensing Device

The details of construction of those portions of the apparatus 100 otherthan the cartridge assembly 106 are best shown in FIGS. 10-24. It willbe understood that the multi-use apparatus of FIGS. 10-24 and the singleuse apparatus of FIG. 25 are shown in schematic form in order toillustrate and describe the major internal working components of thedevice. Further details of the apparatus 100 are explained below withregard to external features of the apparatus 100 which are better shownin the series of FIGS. 2A-2G.

The basic components of the apparatus 100 are most easily understood byviewing the exploded view of FIG. 10. The housing 102, which may bereferred to as a main housing body has a housing interior 202 and anopening 204. The lid 104 is pivotally attached to the main housing body102 and is moveable between a closed position as shown in FIG. 11closing the opening 204 and an open position as shown in FIG. 13 whereinthe housing interior 202 is accessible through the opening 204.

The apparatus 100 includes a container carriage 206 which isreciprocably disposed in the housing body 102. As is illustrated andfurther described with regard to FIGS. 15 and 16 below, the cartridgeassembly 106 including the flexible container 108 will be received inthe carriage 206 so that the carriage 206, the container 108 and theneedle 144 are moveable together within the housing 102 between a firstcarriage position illustrated in FIGS. 18, 18A-A and 18B-B and a secondcarriage position illustrated in FIGS. 20, 20A-A and 20B-B,corresponding to first and second positions of the needle 144,respectively.

A needle return chassis 208 cooperates with the container carriage 206and is also reciprocably disposed in the housing 102 to aid inwithdrawing the needle from its extended position as in FIG. 21 to aretracted safety position as illustrated in FIGS. 23, 24, 24A-A and24B-B.

A roller 210 includes axles such as 212 extending from each end thereofwhich extend through roller tracks or slots 214 and 216 defined in thecontainer carriage 206 so as to guide the roller 210 as it rolls in aproximal direction relative to the container carriage 206 to expelmedicant from the container 108 as will be further described below.

A roller cam 218 has an opening 220 through which the axle 212 extends.The cam 218 is mounted on the outside of the slot 214. Cam 218 includesa mounting pin 219 which extends through a bore 222 in a spool 224attached to a main drive spring 226. The main drive spring 226 is a coilspring strip which has a first end 228 fixed to the main housing body102, and a second end portion 230 which coils around the spool 224 asthe main drive spring 226 contracts to its relaxed position. The coilstrip spring 226 may provide a substantially constant spring force, andthus may be referred to as a constant force spring. When the main drivespring 226 is uncoiled or extended as shown in FIG. 10 it storespotential energy which is utilized to drive the container carriage 206proximally to insert the needle 144 into a patient's body and tosubsequently drive the roller 210 proximally through the containercarriage 206 to roll over the flexible container 108 to expel themedicant therefrom. The main drive spring 226 may be described as beingoperably associated with the container carriage 206, and thus with theneedle 144 attached to the container 108 carried in the containercarriage 206, so as to extend the needle 144 from a first needleposition as shown for example in FIG. 18A-A wherein the needle 144 iscompletely received in the housing 102, to a second needle position asshown for example in FIG. 20A-A wherein the needle 144 protrudes fromthe housing 102.

The main drive spring 226 may also be described as being operablyassociated with the roller 210 to roll the roller 210 over the flexiblecontainer 108 after the needle 144 is extended to its second needleposition. As is further explained below with regard to FIGS. 31-34, theroller 210 may be more generally described as a pump 210, and otheralternative pump structures may be used in other embodiments.

The roller cam 218 may be further described as a roller interlockbetween the roller 210 and the container carriage 206 to prevent theroller 210 from rolling over the flexible container 108 until after themain drive spring 226 moves the needle 144 to its second needleposition.

As will be further described below with regard to FIG. 14A-A, when thelid 104 is opened the roller cam 218 is forced downwardly against thedistal end of the container carriage 206 by a ramp 232 on the outer body102. Thus the roller cam 218 will prevent the roller 210 from rollingproximally relative to the container carriage 206 until after thecontainer carriage 206 has moved proximally to its second containercarriage position as shown for example in FIG. 20A-A.

A retraction spring 234 has a first end 236 connected to a post 238 onthe needle return chassis 208 and a second end 240 connected to a post242 fixed to the bottom floor of the main housing body 102. As isfurther explained below the retraction spring 234 will, at anappropriate time, pull the needle return chassis 208 and the containercarriage 206 and the container 108 and the needle 144 back in a distaldirection to withdraw the needle 144 after the medicant has beenexpelled from the flexible container 108.

The apparatus 100 further includes a cocking linkage 244 connecting thelid 104 to the main drive spring 226 and the retraction spring 234 sothat opening of the lid 104 extends the main drive spring 226 and theretraction spring 234. The cocking linkage 244 includes a number ofcomponents including gears 246 and 248 integrally formed on the distalend of the lid 104, a main drive rack 250, a drive gear 252, and aspring rack 264. The drive gear 262 includes integrally attached smallergear 263 and larger gear 255. The drive gear 252 is mounted on an axle257 extending laterally from the container carriage 206. Thus the drivegear 252 moves laterally with the container carriage 206 within the mainhousing 102. In the position illustrated in FIG. 10, the small gear 253is engaged with the gear teeth of the main drive rack 250, and thelarger gear 255 is engaged with the gear teeth of the spring rack 254.As is further described below, upon actuation of a trigger 270 thespring rack 264 is shifted laterally relative to drive gear 252 out ofengagement with the gear teeth of larger gear 265.

Turning now to FIGS. 11-24 various operating positions of the apparatus100 are illustrated.

When the apparatus 100 is in the position represented by FIGS. 11, 12,12A-A and 12B-B, the apparatus 100 is in an unprimed state after aprevious injection. For ease of illustration, in views 12A-A and 12B-Bno cartridge 106 is shown within the housing, although there wouldtypically be a spent cartridge in place after use of the apparatus 100.

In this position the needle return chassis 208 has moved distally untilit abuts a distal end 209 of the housing 102. That movement isaccomplished by the needle return spring 234. The container carriage 206is also in its distalmost position to which it was carried by engagementof lateral tabs such as 256 and 268 (see FIG. 10) defined on needlereturn chassis 208 with vertical tabs such as 260 extending downwardfrom container carriage 206. In the position of container carriage 206shown in FIG. 12A-A the main drive spring 234, which for ease ofillustration is not shown in FIGS. 12A-A or 12B-B, is in a partiallyextended position to which it has been carried by contraction of thereturn spring 234. As shown in FIG. 12B-B the roller 210 is in aproximalmost position relative to container carriage 206 to whichposition the roller 210 rolled during the prior actuation of theapparatus 100.

Moving now from the position of FIGS. 11 and 12 to the position of FIGS.13 and 14, when the user opens the apparatus 100 by lifting the lid 104from the body 102 the main drive rack 250 is driven forward orproximally thus forcing the needle return chassis 208 forward due toengagement of a cross bar 262 of main drive rack 250 with a downwardextending foot 264 of needle return chassis 208. This extends the needleretraction spring 234. A first trigger 266 shown schematically in FIG.14A-A will engage the needle return chassis 208 to prevent the chassis208 from moving rearwardly or distally after the retraction spring 234has been stretched to full extension as shown in FIG. 14A-A.

Furthermore, in the position of FIG. 14A-A the roller 210 has beenforced to its distalmost position wherein the roller cam 218 has engagedthe ramp 232 and has moved downward to hold the roller 210 in itsdistalmost position relative to the container carriage 206. When theroller 210 is forced distally this also serves to extend the main drivespring 226. These movements have been accomplished by the cockinglinkage 244 upon opening of the lid 104 in the following manner. As thelid 104 pivots upwardly away from the main housing body 102 the gears246 and 248 which are meshed with the teeth of the main drive rack 250force the main drive rack 250 to move proximally within the housing 102.As the main drive rack 260 moves in a proximal direction, it rotates thedrive gear 252 which is rotatably mounted on axle 257 (see FIG. 10) ofcontainer carriage 206. As the drive gear 262 rotates, its larger gearmember is in engagement with the spring rack 264 which drives the springrack 254 in the opposite direction from the main drive rack 250. Thusthe spring rack 254 moves in a distal direction and its distal end 268is engaged with the coil portion 230 of main drive spring 226 and movesthe coil portion 230 distally thus unwinding and stretching or extendingthe main drive spring 226.

A second trigger 270 schematically illustrated in FIG. 14B-B preventsthe container carriage 206 from moving forward or proximally.

With the apparatus 100 in the open position as shown in FIG. 13, acartridge assembly 106 can be placed therein as illustrated in FIG. 15.

Then as shown in FIGS. 17 and 18, the lid 104 is closed and theapparatus 100 is now primed and ready for use. As shown in FIGS. 18A-Aand 18B-B, closing the lid 104 returns the main drive rack 250 to itsdistalmost position leaving the needle return chassis 208 in its cockedor primed position. As previously noted the needle return chassis isheld in position by first trigger 266.

Next, a proximal end 272 of the apparatus 100 is held against thepatient's body and second trigger 270 is fired manually to shift thespring rack 264 sideways thus demeshing the spring rack 264 from thedrive gear 252. This releases the container carriage 206 so that thecontainer carriage 206 is driven forward or proximally by the main drivespring 226. The container carriage 206 carries with it the container 108and the needle hub 140 and needle 144. The needle 144 is driven forwardor proximally to the position shown in FIGS. 19 and 20. During thatmovement, the needle protection frame 154 of cartridge assembly 106 hasremained fixed relative to the housing 102 while the needle hub 140slides proximally over the arms 168 and 160 to a position like thatshown in FIG. 8B.

Thus as the apparatus 100 moves from its position as illustrated byFIGS. 17 and 18 to its position as illustrated by FIGS. 19 and 20, theneedle hub 140 and needle protection frame 154 move relatively betweentheir positions as shown in FIG. 8A to their position as shown in FIG.8B.

It is noted that in FIG. 20, the roller 210 still has not moved forwardwithin the container carriage 206, because the roller cam 218 has heldthe roller 210 in place.

As the container carriage 206 moves forward the roller cam 218 reachesthe end stop on a ramp 219 (see FIG. 10) on the outer body 102 whichforces the roller cam 218 upward thus releasing the roller 210 andallowing the roller 210 to move proximally along the tracks 214 and 216thus rolling over the flexible container 108 to expel the medicanttherefrom. The roller 210 moves from its position as shown in FIG. 20B-Bto its position as shown in FIG. 22B-B. The roller 210 is driven forwardor proximally relative to the container carriage 206 by the furthercontraction of the main drive spring 226. When the roller 210 reachesits forwardmost position as shown in FIG. 22B it trips trigger 266 thusreleasing the needle return chassis 208 which is then drawn backward ordistally due to contraction of the retraction spring 234 thus pullingthe needle return chassis 208 and the container carriage 206 along withthe cartridge assembly 106 and the needle 144 back to their startingpositions as shown in FIGS. 23 and 24 wherein the needle 144 is onceagain withdrawn to a safety position within the housing 202.

During that return motion, the main drive spring 226 is partiallyextended when the container carriage 206 pulls back the roller 210 fromthe position shown in FIG. 22B-B to the position shown in FIG. 24B-B.The apparatus 100 in FIGS. 23 and 24 is now back in the same position atwhich it began in FIGS. 11 and 12.

The first trigger 266 may be described as an interlock 266 operablyassociated with the needle return chassis 208 and the container carriage206. The interlock 266 releases the needle return chassis 208 after theroller 210 expels the medicant from the container 108 so that theretraction spring 234 can withdraw the needle return chassis 208, thecontainer carriage 206, the container 108 and the needle 144 to a safetyposition wherein the needle 144 is fully received back in the housing.

Thus, the apparatus 100 is in condition to again be opened and have thecartridge assembly 106 replaced. Thus the apparatus 100 is a multi-useapparatus which can be used any number of times by replacing thecartridge 106 after use.

When the cartridge 106 is placed in the container carriage 206 twoopenings 274 and 276 (see FIG. 6) in the needle hub 140 receive twoposts 278 and 280 (see FIG. 10) extending upward from the containercarriage 206. A wall 282 of container carriage 206 engages a wall 284(see FIG. 5) of needle hub 140. When the cartridge 106 is in place inthe apparatus 100 the front bar 162 of cartridge 106 is closely receivedin recesses 105 and 107 of housing body 102 and lid 104, respectively,as shown in FIGS. 15 and 17.

Then when the container carriage 206 moves forward in later stages ofoperation it immediately moves the needle hub 140 forward while theneedle protection frame 154 remains fixed in place relative to thehousing 102.

Interlock Requirements

The following Table II describes the required interlocks through onecomplete injection cycle for apparatus 100. In Table II the flexiblecontainer 108 is referred to as a sachet.

TABLE II Full sachet Device Failure Interlock Skin No in Device StateSachet Mode Required Contact Trigger Lid closed Sachet place FiresDevice closed - None None None 1 0 1 0 0 No Drug delivered Derviceopen - None Device Fires, lid snaps shut. Device cannot 1 1 0 0 0 NoPrimed High impact on end stops fire with lid without sachet to dampenopen forces. Device primed - None Device mechanism damaged Device cannot1 1 1 0 0 No Closed hitting end stops hard if fire without a fired.Mechanism abuse sachet in possible (biro type playing) position Deviceopen - Full Device Fires, lid snaps shut. Device cannot 1 1 0 1 1 NoPrimed Drug delivered without body fire with lid contact open Deviceprimed - Full Device fires when not in Device will only 1 1 1 1 1 YesClosed contact with skin. dose lost fire with skin contact Deviceclosed - Used None None 1 0 1 1 0 No Drug delivered Device open - UsedDevice mechanism damaged Device cannot 1 1 0 1 0 No Primed hitting endstops hard if fire with lid fired. Used needle fires again open Deviceprimed - Used Used needle fires a second Sachet locked 1 1 1 1 0 NoClosed time after use

The device trigger 270 must only become unlocked when skin contact ismade with the needle end of the device 100.

The ‘no sachet’ interlock and ‘used sachet’ interlock could become onefeature if there was a permanently displaceable component on thecontainer carriage 208 that interacted with the ‘no sachet’ interlock.

The ‘lid closed’ interlock must be well recessed to prevent activationby any means other than the lid 104 being closed in place. This mayinclude multiple contact points.

Fixed Roller Embodiments of FIGS. 27-30 FIG. 27

In the embodiments of FIGS. 1-24 described above, during the relativemovement between the roller and the flexible container wherein themedicant is expelled from the flexible container, the flexible containerhas been held in a fixed position relative to the housing and the rollerhas moved longitudinally relative to the housing to roll over theflexible container to expel the medicant. It is also possible to achievethe same relative motion between the roller and the flexible containerby holding the roller in a fixed position relative to the housing whilemoving the flexible container in a longitudinal direction relative tothe housing. Several such arrangements are schematically illustrated inFIGS. 27-30.

FIG. 27 schematically shows an injection apparatus 300 including acartridge 302 carried in a container carriage 304. The containercarriage 304 functions in a manner similar to the container carriage 206described above and is powered by a main drive spring (not shown) whichmay be a coil strip main drive spring similar to drive spring 226described above. The carriage 304 and the drive spring are received in ahousing (not shown) similar to housing 102 described above.

The cartridge 302 includes a needle hub 306 having a needle 308extending proximally therefrom. A roller 310 having first and secondcoaxial spaced roller portions 312 and 314 is longitudinally fixedrelative to the housing so that the roller 310 rotates relative to thehousing but does not move longitudinally relative to the housing. Theneedle 308 extends between the roller portions 312 and 314. The rollerportions 312 and 314 engage first and second flexible containers 820 and322 which are communicated at their distal ends with needle hub 306 andthus with needle 308.

As the container carriage 304 begins moving in the direction 316relative to the housing and relative to the longitudinally fixed rollers310, the needle 308 will pierce a flexible needle protective sleeve 318and will be inserted into a patient's body. Further movement of thecontainer carriage 304 moves the first and second flexible containercompartments 320 and 322 past the fixed rollers 312 and 314 so that therollers squeeze the medicant contained in the flexible containers 320and 322 out through the needle hub 306 and through the needle 308 intothe patient's body.

With the embodiment of FIG. 27, as the container carriage 304 movesforward the needle 308 will continue to be inserted deeper into thepatient's body while the medicant is simultaneously being expelledthrough the needle 308 into the patient's body. Thus some portion of theneedle insertion and the drug injection can occur simultaneously.

In all applicable respects other than the geometry of the arrangement,the details of construction of the flexible containers 320 and 322, theneedle hub 306 and other components of the apparatus 300 will be similarto those of the apparatus 100 described in detail above.

FIG. 28

FIG. 28 schematically illustrates an embodiment somewhat similar to thatof FIG. 27, except in the embodiment of FIG. 28, a secondary carriage isprovided to first partially insert the needle into the patient's body.

Thus in FIG. 28 an apparatus 400 is shown including a cartridge 402carried in a container carriage 404 which is in turn carried in asecondary carriage 424. The apparatus 400 includes needle hub 406,needle 408, roller 410 with roller portions 412 and 414, sheath 418 andflexible containers 420 and 422 all similar to the analogous componentsdescribed above with regard to FIG. 27. The roller portions 412 and 414are longitudinally fixed to the secondary carriage 424.

The secondary carriage 424 carries the container carriage 404 andaccompanying components to initially insert the needle 408 into thepatient's body. Then further motion of the container carriage 404relative to the secondary carriage 424 moves first and second flexiblecontainer compartments 420 and 422 past first and second roller portions412 and 414 of roller 410 in the direction 416 to expel the medicantfrom the container portions 420 and 422 and into the patient.

The motion of container carriage 404 relative to secondary carriage 424,and the motion of secondary carriage 424 relative to the housing (notshown) may be driven by any suitable spring or other power source, suchas coil strip springs like 226 or helical springs like 234.

FIG. 29

FIG. 29 schematically illustrates another embodiment of the fixed rollerapparatus which is generally designated by the numeral 600.

The apparatus 500, similar to the apparatus 300 of FIG. 27, includes aU-shape or dual chamber flexible container 602 having first and secondcontainer portions 604 and 506. A bottom portion 508 of the U-shapeflexible container 502 may include a needle hub similar to the needlehub 306 and similar to the needle hub 140 described above.

A needle 609 extends proximally from the needle hub 508. Proximal ends510 and 512 of the flexible container portions 504 and 506 are attachedto a pull bar 614. Intermediate portions 516 and 518 of the first andsecond container portions 504 and 606 are wrapped around first andsecond roller portions 620 and 522 of roller 524. The roller 524 isfixedly attached to the apparatus housing (not shown) so as to rotaterelative to the housing without moving longitudinally relative to thehousing.

A main drive spring (not shown) attached to the pull bar 514 pulls thepull bar 514 in a distal direction as indicated by arrow 626. Thiscauses the portions of the flexible containers 504 and 506 located abovethe roller 524 to be pulled distally while the portions of the flexiblecontainers 604 and 506 located below the roller 524 move proximally inthe direction indicated by arrow 528.

As those lower portions of the flexible container move proximally, theypull forward the needle hub 608 and the attached needle 609 moving themproximally so as to insert the needle 509 in the patient and to expelmedicant from the container portions 504 and 506 through the needle 609into the patient. The container portions 504 and 506 may initially beonly partially filled so that the initial forward motion of needle 509to insert the needle into the patient's body may occur before the drugbegins to be expelled through the needle.

With the embodiment of FIG. 29 the initial proximal movement of theneedle 609 serves to collapse a needle protection sheath 530 and insertthe needle 509 into the patient, and continued proximal movement of theneedle 509 will further insert the needle 509 into the patient whilemedicant is simultaneously expelled from the flexible container portions604 and 506 through the needle 509 into the patient.

FIG. 30

FIG. 30 schematically illustrates a further embodiment identified by thenumeral 600 which is similar to the embodiment of FIG. 29 except that itadds a secondary carriage 602. Other components are numbered the same asin FIG. 29.

The secondary carriage 602 provides an initial proximal movement indirection 528 of the entire flexible container 602 and associatedstructures of FIG. 29, to an initial position which will insert theneedle 509 into the patient. Then a main drive spring (not shown)initiates the motion of the pull bar 614 in the direction 626 relativeto the secondary carriage 602 and the main housing to further inject theneedle 509 and expel the medicant from the flexible container 502.

In general, with regard to all of the embodiments described above, theroller can be said to engage its associated flexible container and expelthe medicant from the container through the needle upon relativemovement between the roller and the container. In each case the rollerhas a rotational axis and the relative movement between the roller andthe container is a relative longitudinal movement in a longitudinaldirection transverse to the rotational axis.

In some embodiments such as those of FIGS. 10-25, the flexible containeris longitudinally fixed relative to the housing during the injectionprocess, and the roller moves longitudinally relative to the containerand the housing. In other embodiments such as FIGS. 27-30, the roller islongitudinally fixed relative to the housing during the injectionprocess, and the container moves longitudinally relative to the rollerand the housing.

Single Use Embodiment of FIG. 25

FIG. 25 is a schematic perspective exploded view of a single useembodiment of the auto-injector apparatus. FIG. 25 is similar in manyaspects to FIG. 10, and those components of FIG. 25 identical to thecomponents of FIG. 10 are identified with the same numerals as used inFIG. 10, and those components which have been modified are indicatedwith a prime suffix. Thus the apparatus of FIG. 26 is referred to as theapparatus 100′. The housing includes a main housing body 102′ and a lid104′, however the lid is not designed for repeated opening and closing.Instead, the lid 104′ is designed to be permanently attached to the mainhousing body 102′ so that the housing 102′, 104′ comprises a closedsingle use housing having an interior 202 which is inaccessible by auser without damage to the housing.

The single use apparatus 100′ may utilize the same container carriage206, roller 210, roller cam 218, main drive spring 226, return chassis208, and retraction spring 234 as were described above with regard tothe multi-use apparatus 100.

The primary deletions from the apparatus 100 of FIG. 10 include thecocking linkage 244 and its gears 246 and 248, the main drive rack 250,the drive gear 252, and the spring rack 264, all of which have beeneliminated because there is no need for opening of the housing orreloading of the housing with a cartridge.

Although not shown in FIG. 26, the single use apparatus 100′ will usethe same cartridge assembly 106 as described above, which will becarried in the container carriage 206 in the same manner as describedabove with regard to the apparatus 100. The difference is that a singlecartridge 102 will be placed within the apparatus 100′ prior to sealingthe lid 104′ on the main housing body 102′, and there is no replacementof that cartridge after use. Thus when the apparatus 100 is assembled, acartridge 106 is placed within the cartridge carrier 206. The roller210, roller cam 218, main drive spring 226, container carriage 206,return chassis 208 and retraction spring 234 are all placed in positionsanalogous to those shown in FIGS. 17, 18, 18A-A and 18B-B. The triggers266 and 270 as shown in FIG. 18A-A are in place.

External Packaging for Single Use Embodiment

FIGS. 41 and 42-43 show two different types of external packaging thatcan be used with the single use injector device 100′.

In FIG. 41 the device 100′ is contained in an opaque, preferably metalfoil, outer package 740 which is constructed like the package 700described above with regard to FIG. 36. Package 740 has notches 742 and744 which allow the user to tear the package open to access the singleuse device 100′. The device 100′ has a transparent window 746 formed inthe front thereof so that the flexible container 108 of the cartridge106 contained therein may be viewed to confirm that the container 108 isfilled with medicant prior to use of the device 100′.

FIGS. 42 and 43 show a single use device 760 similar to the device 100′of FIG. 26, but with a transparent window 762 formed in the frontthereof. The window 762 is initially blocked in FIG. 42 by an opaquepull strip 764. Prior to use of the apparatus 760, the strip 764 ispulled to a second position as shown in FIG. 43, thus exposing thecartridge 106 to view through the transparent window 762. This allowsthe transparent flexible container 108 of the cartridge 106 to be viewedthrough the window 762 to confirm that the container 108 is full ofmedicant prior to use of the device 760, and to confirm that themedicant is clear and free of particulates. A second transparent windowand pull strip is preferably provided on the other side of the device760 to allow a see through inspection of the container 108. The pullstrips preferably are constructed as integral portions of a secondarypackage around the flexible container 108, so that portions of thepackage are peeled back to expose the container 108 when the pull stripsare pulled. The secondary container including the pull strips shouldblock exposure of the container 108 to light passing through the window762 prior to pulling the pull stripe.

Methods of Use

The methods of use of the apparatus will now be described with regard toFIGS. 9-24 and the schematic views of FIGS. 2A-2G.

One example of a method of auto-injecting a liquid medicant into apatient may include:

-   -   (a) Placing a proximal end 272 of an auto-injector apparatus 100        or 100′ against a patient's body 101—the patient's body 101 is        only schematically illustrated and may for example be an arm or        thigh of the patient such as typically used as an injection        site;    -   (b) Releasing a main drive spring 226 such as for example by        manually releasing second trigger 270 by depressing the same as        indicated by arrow 103 in FIG. 2E;    -   (c) Driving the needle 144 proximally within the apparatus 100        or 100′ with the main drive spring 226 so that the needle 144        extends out of the proximal end 272 of the apparatus 100 or 100′        thereby inserting the needle 144 in the patient's body 101; and    -   (d) Creating relative motion between roller 210 and flexible        container 108 by rolling the roller 210 over the flexible        medicant container 108 within the apparatus 100 or 100′ with the        main drive spring 226 after or while the needle 144 is being        inserted in the patient's body 101 and thereby forcing the        medicant out of the medicant container 108 through the needle        144 into the patient's body 101. During the relative motion        between the roller and the flexible container to force the        medicant out of the container, a frangible seal within the        flexible medicant container is broken so that the medicant can        flow from the container to the needle.

After injecting the medicant into the patient's body, the needle returnchassis 208 is released to retract the needle 144 back into theapparatus 100 or 100′ with the retraction spring 234 as shown forexample in FIG. 2G and in FIGS. 23, 24, 24A-A and 24B-B.

Those steps just described are applicable to both the multi-useapparatus 100 of FIGS. 10-24 and the single use apparatus 100′ of FIG.25.

For the multi-use apparatus 100 of FIGS. 10-24, the apparatus canfurther be reloaded by opening the lid 104 of the apparatus 100 toprovide access to the interior 202. That opening action extends the maindrive spring 236 and the retraction spring 234 so that the springs 236and 234 are in position to repeat the insertion of the needle andinjection of the medicant into the patient. After opening the lid, thespent medicant container 106 including its needle 144 is removed fromthe apparatus 100 and a new medicant container and needle assembly 106are placed in the apparatus 100.

The overall method of operation of the multi-use apparatus 100 of FIGS.10-24 is schematically illustrated in the seven sequential positions setforth in FIGS. 2A-2G. It is noted that the seven steps represented byFIGS. 2A-2G correspond to the seven positions of the apparatus 100illustrated in FIGS. 11, 13, 16, 17, 19, 21 and 23, respectively.

Thus, in FIG. 2A, FIG. 11, FIG. 12, FIG. 12A-A and FIG. 12B-B, theapparatus 100 begins in an unprimed state after the previous injection.

In FIG. 2B, FIG. 13, FIG. 14, FIG. 14A-A and FIG. 14B-B the lid 104 ofthe apparatus 100 has been opened. This has reset the main drive spring226 and the retraction spring 234, and has moved roller 210, containercarriage 206 and needle return chassis 208 to the positions illustratedin FIGS. 14A-A and 14B-B.

In FIG. 2C, FIG. 16, FIG. 16, FIG. 16A-A and FIG. 16B-B a new cartridgeassembly 106 has been inserted into the apparatus 100.

In FIG. 2D, FIG. 17, FIG. 18, FIG. 18A-A and FIG. 18B-B the lid 104 hasbeen closed and the apparatus 100 is primed and ready for use.

In FIG. 2E, FIG. 19, FIG. 20, FIG. 20A-A and FIG. 20B-B the distal end272 of the apparatus 100 is held against the patient's body 101 and thetrigger 270 is fired manually by the user depressing the same with athumb as indicated by arrow 103. The trigger 270 shifts the spring rack254 sideways thus demeshing it from the drive gear 252 which releasesthe container carriage 206 which is then driven forward by the maindrive spring 226 thus driving the needle 144 into the patient's body101.

It is noted that in FIG. 2E the needle 144 is not shown, whereas theneedle 144 is shown protruding from the housing 102 in FIGS. 19 and 20.It will be understood that as a result of actuating the trigger 270 asindicated in FIG. 2E the needle 144 will move forward and will protrudefrom the apparatus 100 into the patient's body 101 as shown for examplein FIG. 2F.

FIG. 2F, FIG. 21, FIG. 22, FIG. 22A-A and FIG. 22B-B illustrate theposition of the various components of the apparatus 100 after the maindrive spring 226 has driven the roller 210 forward to expel the liquidmedicant from the flexible container. When the roller reaches the end ofits travel it trips trigger 266.

FIG. 2G, FIG. 23, FIG. 24, FIG. 24A-A and FIG. 24B-B illustrate theposition of the components after trigger 266 has released the needlereturn chassis 208 so that the retraction spring 234 draws the needlereturn chassis 208, the container carriage 206 and the cartridgeassembly 106 back within the housing thus withdrawing the needle 144from the patient.

In the arrangement just described with reference to FIGS. 2A-2G theproximal end 272 was first pressed against the patient's body to arm thedevice, and then trigger 270 was pressed to fire the device.Alternatively the various interlocks between the operating componentscan be arranged so that the trigger 270 must first be pressed to arm thedevice, and then when distal end 272 is pressed against the patient'sbody the device will automatically fire.

The Alternative Pump Embodiments of FIGS. 31-34 FIGS. 31A-31B

As previously noted, the roller 210 may be generally described as a pump210 disposed in the housing and positioned to engage the flexiblecontainer 108 and expel the medicant from the container 108 through theneedle 144. FIGS. 31-34 schematically illustrate alternative pumparrangements which could be substituted for the roller pump 210.

In FIGS. 31A and 31B a pump 610 includes an inflatable balloon orbladder 612 powered by compressed gas or expanding chemical reactionproducing reaction gases from gas source 614 via conduit 616.

In FIG. 31A the balloon pump 610, 612 is schematically shown in anuninflated position. In FIG. 31B the pump 610, 612 is schematicallyshown in an inflated position. As the balloon 612 inflates within thehousing, it acts against the flexible container 108 thus compressing theflexible container 108 to a compressed condition as shown in FIG. 31Bwhich expels the medicant from the container 108 through the frangibleseal 143 to the needle hub 140. The expanding balloon 612 appliespressure to the flexible container 108 thus squeezing the flexiblecontainer 108 from its original condition shown in FIG. 31A to itscompressed position shown in FIG. 31B.

FIGS. 32A-32B

Referring now to FIGS. 32A-32B, a magnetic pump 620 includes a pair ofmagnets 622 and 624. The magnets at one end are pivotally connected at626. At the other end a mechanical blocking device schematicallyindicated at 628 holds the magnets apart so as to define a gap 630therebetween within which the flexible container 108 is located. Uponremoving the mechanical blocker 628, the magnet 622 moves toward themagnet 624 thus closing the gap 630 and applying pressure to theflexible container 108 to collapse the flexible container 108 to aposition such as schematically illustrated in FIG. 32B, thus expellingthe medicant from the flexible container 108. The magnetic pump 620 canbe described as comprising a pair of magnets 622 and 624 on oppositesides of the flexible container 108.

FIGS. 33A-33B

FIGS. 33A-33B schematically illustrate an electromagnetic pump 640 whichincludes an electromagnet 642 and a magnetically attractive mass 644 onopposite sides of the flexible container 108. The electromagnet 642 maybe an electric coil type magnet which receives electrical power frombattery 646 via wires 648. The magnetically attractive mass 644 may be asteel plate. In the unactuated position of FIG. 33A a gap 650 is definedbetween electromagnet 642 and steel plate 644, and the flexiblecontainer 108 is located in the gap 660.

When current from battery 646 is applied to the coil of electromagnet642 the steel plate 644 is drawn toward electromagnet 642 thus closingthe gap 660 and compressing the flexible container 108 to a conditionlike that schematically illustrated in FIG. 33B, thus squeezing themedicant out of the flexible container 108 through the frangible seal143 to the needle hub 140. The steel plate 644 may ride on guideposts662 and 654 extending upwardly from the electromagnet 642.

FIGS. 34A-34B

FIGS. 34A and 34B schematically illustrate an alternative pump apparatus660 wherein the pump comprises construction of the flexible container108 from a resilient material so the container can be pressurized to anexpanded position as shown in FIG. 34A. When it is desired to expel themedicant from the flexible container 108, the frangible seal 143 isbreached by any suitable means, thus allowing the stretched walls ofcontainer 108 to retract to the position of FIG. 34B, thus forcing themedicant out of container 108 and past breached seal 143 to needle hub140.

Thus it is seen that the apparatus and methods of the present inventionreadily achieve the ends and advantages mentioned as well as thoseinherent therein. While certain preferred embodiments of the inventionhave been illustrated and described for purposes of the presentdisclosure, numerous changes in the arrangement and construction ofparts and steps may be made by those skilled in the art, which changesare encompassed within the scope and spirit of the present invention asdefined by the appended claims.

What is claimed is:
 1. An auto-injector apparatus, comprising: aflexible container containing a liquid medicant; a needle communicatedwith the container; a housing, the container being received in thehousing; a pump disposed in the housing and positioned to engage theflexible container and expel the medicant from the container through theneedle upon relative movement between the pump and the container; and amain drive spring operably associated with the needle to extend theneedle from a first needle position wherein the needle is completelyreceived in the housing to a second needle position wherein the needleprotrudes from the housing.
 2. The apparatus of claim 1, wherein: themain drive spring is operably associated with the pump to create therelative movement between the pump and the flexible container.
 3. Theapparatus of claim 2, further comprising: a retraction spring operablyassociated with the needle to retract the needle back into the housingafter the medicant is expelled from the container.
 4. The apparatus ofclaim 1, further comprising: a container carriage reciprocably disposedin the housing, the container being received in the carriage so that thecarriage, the container and the needle are movable together within thehousing between first and second carriage positions corresponding to thefirst and second needle positions.
 5. The apparatus of claim 4, furthercomprising: a needle return chassis; a retraction spring connectedbetween the housing and the needle return chassis; an interlock operablyassociated with the needle return chassis and the container carriage,the interlock releasing the needle return chassis after the pump expelsthe medicant from the container so that the retraction spring canwithdraw the needle return chassis, the container carriage, thecontainer and the needle to a safety position wherein the needle isfully received back in the housing.
 6. The apparatus of claim 4,wherein: the pump includes a roller; the container carriage includes aroller track; and the roller is received in the roller track so that theroller is guided by the roller track as the roller rolls over theflexible container.
 7. The apparatus of claim 6, further comprising: aroller interlock between the roller and the container carriage toprevent the roller from rolling over the flexible container until afterthe main drive spring moves the needle to its second needle position. 8.The apparatus of claim 1, further comprising: a needle hub connected tothe flexible container, the needle being attached to the needle hub andincluding a needle proximal end extending proximally from the needlehub; and a needle protection frame slidably connected to the needle hub,the needle hub being slidable relative to the frame from a first hubposition wherein the frame extends proximally beyond the needle proximalend, to a second hub position wherein the needle proximal end extendsproximally beyond the frame.
 9. The apparatus of claim 8, furthercomprising: a collapsible needle sheath supported by the frame andcovering the needle to aid in maintaining sterility of the needle whenthe needle hub is in its first hub position relative to the frame. 10.The apparatus of claim 1, wherein: the main drive spring comprises acoiled spring strip.
 11. The apparatus of claim 1, wherein: the housingcomprises a closed single use housing having an interior inaccessible bya user without damage to the housing.
 12. The apparatus of claim 11,further comprising: the housing having a transparent window thereinthrough which the flexible container is visible; and an opaque secondarycontainer in which the housing is sealed.
 13. The apparatus of claim 11,further comprising: the housing having a transparent window thereinthrough which the flexible container can be viewed; and a pull stripmovable between a first position blocking the transparent window and asecond position wherein the transparent window is unblocked so that theflexible container can be viewed prior to use.
 14. The apparatus ofclaim 1, wherein the pump comprises a roller.
 15. The apparatus of claim14, wherein: the roller has a rotational axis, and the relative movementbetween the roller and the container is a relative longitudinal movementin a longitudinal direction transverse to the rotational axis, and thecontainer is longitudinally fixed relative to the housing during atleast part of the relative longitudinal movement between the roller andthe container.
 16. The apparatus of claim 14, wherein: the roller has arotational axis, and the relative movement between the roller and thecontainer is a relative longitudinal movement in a longitudinaldirection transverse to the rotational axis, and the roller islongitudinally fixed relative to the housing during at least part of therelative longitudinal movement between the roller and the container. 17.The apparatus of claim 16, wherein: the roller includes two spacedco-axial roller portions; and the needle extends between the rollerportions.
 18. The apparatus of claim 1, wherein the pump comprises aninflatable balloon.
 19. The apparatus of claim 1, wherein the pumpcomprises a pair of magnets on opposite sides of the flexible container.20. The apparatus of claim 1, wherein the pump comprises anelectro-magnet and a magnetically attracted mass on opposite sides ofthe flexible container.
 21. The apparatus of claim 1, wherein the pumpcomprises a source of fluid pressure communicated with the interior ofthe flexible container.